DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

K061251 · Dade Behring, Inc. · JIS · May 31, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061251
• Device Name: DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The TIBC Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

Device Story

Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin-based product containing human transferrin. Used for calibration of TIBC method on Dimension Vista™ System. Kit includes three vials (1.0 mL each); zero level calibrator is system water provided on-board. Product prepared by adding human transferrin to base matrix via gravimetric procedures; concentration verified against NIST SRM937. Used by laboratory professionals in clinical settings to ensure accuracy of TIBC assays. Benefits patient by providing standardized calibration for iron binding capacity measurements, supporting clinical assessment of iron status.

Clinical Evidence

No clinical data. Bench testing only. Stability studies included shelf-life (up to 735 days at 4°C), freeze-thaw, stress testing, and open-vial stability. Traceability established to NIST SRM937. Donor units tested negative for HIV-1, HIV-2, HBsAg, and HCV.

Technological Characteristics

Liquid, bovine albumin-based matrix containing human transferrin. Traceable to NIST SRM937. Designed for use on the Dimension Vista™ System. Sterility/biohazard control: donor units tested for HIV-1/2, HBsAg, and HCV.

Indications for Use

Indicated for use in the calibration of the TIBC method on the Dimension Vista™ system for prescription use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® IBCT Calibrator (k994114)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k061251

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for total iron binding capacity

D. Type of Test:
Not Applicable

E. Applicant:
Dade Behring Inc.

F. Proprietary and Established Names:
Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150
2. Classification:
Class II
3. Product code:
JIS
4. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):

The TIBC CAL is an in vitro diagnostic product for the calibration of Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ System.

2. Indication(s) for use:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is intended for use in the calibration of the TIBC method on the Dimension Vista™ system.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Dimension Vista™ System

I. Device Description:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of three vials, each containing 1.0 mL. The zero level calibrator is system water provided on board the instrument.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension® IBCT Calibrator

2. Predicate 510(k) number(s):

k994114

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indications for Use | Calibration of total iron binding capacity method | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Human transferrin | Same |
| Matrix | Bovine Albumin | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | One | Three |
| Instrument | Dimension Vista™ System | Dimension® Clinical Chemistry System |

# K. Standard/Guidance Document Referenced (if applicable):

National Institute of Standards and Technology (NIST) Iron Standard - SRM937

# L. Test Principle:

Refer to the calibration procedure is in the Calibration section of the Operator's Guide for the Dimension Vista™ System.

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The Primary Standards are traceable to NIST reference material (SRM937).

TIBC calibrator is prepared in a bovine albumin base matrix. A calculated quantity of human transferrin is added to the base material using standard gravimetric procedures. The concentration is verified to be within acceptable ranges using an instrument calibrated with Primary Standards. The values are assigned to each lot using multiple reagent lots on multiple instruments.

Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency

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Virus Type 1 (HIV-1) and Type 2 (HIV-2), as well as for Hepatitis B Surface Antigen (HBsAg) and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive).

Several studies are conducted to support product stability:

For shelf life testing, product is stored at 4°C throughout the testing cycle and tested on days 0, 3, 7, 35, 98, 189, 280, 325, 371, 462, 553, 664, and 735. Identical lot of calibrator product stored at -20°C and tested at the same frequency.

For freeze – thaw testing, the product is frozen and thawed three times over three days and then stored at 4°C. Testing occurs over a 13 month period.

For stress testing, the product is first stored at 30°C for 36 hours, 35°C for 12 hours, and then 45°C for 4 hours. Next, the product is stored at 25°C for 48 hours, then 30°C for 6 hours. Lastly, the product is stored at 15°C for 54 hours. After storage at these three conditions, the calibrators are stored at 4°C and tested over a 24.5 month period.

For open vial stability testing, vials are opened/punctured on day zero. A portion for multiple calibrations is removed and the vials are recapped and stored at 2-8°C. Opened/punctured vials are tested on days 1, 8, 15, 22, 32 vs. freshly opened vials.

The 4°C material values are recovered vs. the calibrations. Recovery vs. time is monitored and percent change over time is determined.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

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b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.